The Pain and Anxiety in Children With Intramuscular Injection

NCT ID: NCT05444634

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pharmacological and non-pharmacological methods are used in the management of pain and anxiety in children. Non-pharmacological methods are noninvasive, inexpensive, have no side effects and are independent functions of the nurse.This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection. The study was conducted between May 2022 and August 2022. It will be done with children aged 3-6 years who come to the emergency unit of the State Hospital, who are given intramuscular injection.

"Descriptive Information Form", "Wong Baker Faces Pain Rating Scale", "Venham Anxiety Rating Picture Scale" will be used in data collection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intramuscular Myxoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

distraction card

Immediately before the procedure, the child will be asked questions about the distraction cards. Questions about the cards will continue to be asked immediately after the intramuscular injection is finished.

Group Type EXPERIMENTAL

Distraction Card

Intervention Type BEHAVIORAL

Suitable for children over 3 years old. 1 set of 32 pieces of thick cardboard cards It has been prepared by child development experts in line with pedagogical principles.

Size: 13cm x 8cm, Each card illustrates the skills and actions the children do.

Stress Ball

The child will be informed about the stress ball and asked to play continuously

Group Type EXPERIMENTAL

Stress Ball

Intervention Type BEHAVIORAL

Brain Shaped Stress Ball, White rope in the form of mesh around the inner silicone Size: Approx 2.4 inches (6 cm), Color: Colorful, When squeezed, the silicone structure comes out in the mesh spaces and turns into a bunch of grapes.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Distraction Card

Suitable for children over 3 years old. 1 set of 32 pieces of thick cardboard cards It has been prepared by child development experts in line with pedagogical principles.

Size: 13cm x 8cm, Each card illustrates the skills and actions the children do.

Intervention Type BEHAVIORAL

Stress Ball

Brain Shaped Stress Ball, White rope in the form of mesh around the inner silicone Size: Approx 2.4 inches (6 cm), Color: Colorful, When squeezed, the silicone structure comes out in the mesh spaces and turns into a bunch of grapes.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 3-6 years old
* Intramuscular administration of ondansetron hcl active ingredient drug
* Mentally and physically handicapped
* Does not have a disease that causes chronic pain
* Open to communication
* Fluent in Turkish

Exclusion Criteria

* Children of parents who did not give written consent
* Children who do not give verbal consent appropriate to the child's developmental level
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MSc Merve Eroğlu

UNKNOWN

Sponsor Role collaborator

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Türkan Kadiroğlu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ataturk University

Erzurum, Erzuum, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B.30.2.ATA.O.01.00/265

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.